Widely used nucleic amplification technologies (NATs) are based on polymerase chain reaction (PCR), whose foundational patents expired in the US in March 2005, patent expiry is expected to unlock considerable market opportunities.
Smaller companies entering the lucrative clinical kits market may offer tests without developing a nucleic acid technology, which will normally require heavy R&D investment.
"PCR patent expiry would have a profound impact in the academic research kits market which is highly price sensitive. This segment will see enhanced competition from cheaper products," says Technical Insights Industry Analyst Mr. S. Ravi Shankar.
"Patent expiry will, also, lead to a rise in competition to reduce the PCR reagent cost and instrumentation."
Despite the patent expiry that is likely to increase demand for NAT technology, the dampener lies in the persistent popularity of traditional nucleic acid separation methods such as plasmid isolation.
Due to consumer indifference, less common nucleic acid isolation techniques such as genomic deoxyribonucleic acid (DNA) from fungi have experienced a lesser degree of commercial product penetration.
Furthermore, as the number of organisms researched increases exponentially, manufacturers are not able to keep up with product line diversity, thus continuing the research community's reliance on traditional nucleic acid separation methods, such as phenol-chloroform extraction.
Also, with funding resources becoming scarcer, researchers are looking for viable alternatives to meet their growing need for inexpensive sample preparation.
As the scientific community transitions from sequencing to functional genomics, there will be a greater need for consistently pure nucleic acid samples, which will drive demand for automated instrumentation products.
"Through the development of more sophisticated systems, the time currently spent on manual sample preparation and detection could be significantly reduced," explains Mr. Shankar.
"A major trend in instrumentation systems is an increase in the number of manufacturers that are focusing on low-throughput isolation instrumentation."
The need for quantitative assays due to Europe's increasing unmonitored population and EU's In Vitro Diagnostic Directive (IVDD) that requires approval will convince end users to favour commercial kits.
European Advances in Nucleic Acid Purification and Amplification Technologies is part of the Technical Insights Healthcare vertical subscription service and it defines key markets and applications and reports on technology drivers as well as obstacles in the way of commercial success.
It also provides a detailed overview of technological advances in development laboratories; identifies key companies and developers; and provides estimates of timelines for commercialising technology.